Global Regulatory Project Lead – Veterinary Biologics

About the role

Elanco is seeking a Global Regulatory Project Lead to drive regulatory strategy for innovative veterinary biologics and large‑molecule products. You will own the EU and USA regulatory approach, guiding projects from pre‑approval through life‑cycle management.

Key responsibilities

• Lead global regulatory strategy, submission planning and technical dossier development for biologics projects, with direct responsibility for EU and USA activities.
• Manage pre‑approval and development‑driven life‑cycle tasks, including clinical trial submission plans and Quality, Safety, and Effectiveness content for agency interactions.
• Partner with R&D, marketing, supply chain, manufacturing, quality, finance, legal and technical services to assess regulatory impact on product development, labeling, timelines and resources.
• Engage with EU and USA regulatory agencies and coordinate with regional leaders to support first‑wave registrations in additional key markets.
• Identify regulatory risks and opportunities, prioritize resources and help develop SOPs, policies and guidance for compliance.

Required profile

• Master’s degree or higher in veterinary medicine, biologics, infectious diseases, immunology or a related life‑science field.
• At least 10 years of experience in the animal health industry with direct regulatory affairs responsibility for biologics or large‑molecule products.
• Proven regulatory leadership and dossier registration experience across pre‑approval and life‑cycle management in the EU and/or USA.
• Strong knowledge of global regulatory procedures for new veterinary medicinal products.

Required skills